A Study to Evaluate NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Associated With Parkinson's Disease or Prodromal or Manifest Lewy Body Dementia
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Aptinyx
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Change from baseline in vital signs, clinical laboratory values, and electrocardiogram results
研究概览
简要总结
A Study to Evaluate NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Associated With Parkinson's Disease or Prodromal or Manifest Lewy Body Dementia
详细描述
The study will be a 16 to 18-week study, including a 2 to 4-week screening period, followed by a 12-week double-blind, randomized, placebo-controlled treatment Period, and a 2-week follow-up period. Subjects eligible for the study will be randomized to receive either NYX-458 or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent
- •Diagnosis of Parkinson's disease and mild cognitive impairment or mild dementia OR diagnosis of mild cognitive impairment or mild dementia with Lewy bodies
- •Presence of subjective cognitive complaints by the patient
- •Verifiable impairment, as defined a CGI-S (Clinical Global Impression-Severity) score of at least 3 (mildly ill).
- •Score on the MoCA (Montreal Cognitive Assessment) between 15 and 25, inclusive.
- •Stable anti-parkinsonian regimen (if applicable)
- •Has a study partner who can accompany the subject at specified study visits
排除标准
- •Clinically meaningful motor complications
- •Current use of medications with primarily central nervous system activities
- •Other clinically significant medical histories that may interfere with completing the study.
研究组 & 干预措施
Placebo
Matching placebo Capsules
干预措施: Placebo Oral Capsule (Drug)
NYX-458 30 mg
Single oral dose taken daily for 12 weeks.
干预措施: NYX-458 (Drug)
结局指标
主要结局
Change from baseline in vital signs, clinical laboratory values, and electrocardiogram results
时间窗: Subjects will be followed up to 14 days post-dose
Vital signs, clinical laboratory values, and electrocardiogram results
Change from baseline dissociative effects, psychosis, and hallucinatory symptoms as measured by the Neuropsychiatric Inventory (NPI-12)
时间窗: Subjects will be followed up to 14 days post-dose
Neuropsychiatric Inventory (NPI-12) - NPI-12 assesses 12 behavioral domains common in dementia. Higher scores indicate more severe illness.
Change from baseline in physical examination
时间窗: Subjects will be followed up to 14 days post-dose
Physical examination
Rates of adverse events and serious adverse events
时间窗: Subjects will be followed up to 14 days post-dose
Adverse events and serious adverse events
Rates of early termination due to adverse events
时间窗: Subjects will be followed up to 14 days post-dose
Early termination due to adverse events
Change from baseline in suicidal ideation and behavior as measured by the Sheehan Suicidality Tracking Scale (S-STS)
时间窗: Subjects will be followed up to 14 days post-dose
Sheehan Suicidality Tracking Scale (S-STS) is a 16-item scale that assesses the seriousness of suicidality phenomena on a likert-type scale (0 to 4) ranging from 0 = not at all to 4 = extremely
Change from baseline in motor complications as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 4
时间窗: Subjects will be followed up to 14 days post-dose
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 4 includes 6 items assessing motor complications, higher scores indicate more serious illness.
Change in total score of the Sheehan Suicidality Tracking Scale (S-STS)
时间窗: Subjects will be followed up to 14 days post-dose
Sheehan Suicidality Tracking Scale (S-STS) is a 16-item scale that assesses the seriousness of suicidality phenomena on a likert-type scale (0 to 4) ranging from 0 = not at all to 4 = extremely
次要结局
- Change from baseline in the One Back test(Week 12)
- Change from baseline in the Two Back test(Week 12)
- Change from baseline in the Groton Maze Learning Test(Week 12)
- Change from baseline in the Identification Test(Week 12)
- Change from baseline in the International Shopping List Test(Week 12)
- Change from baseline on Continuous Paired Associate Learning Test(Week 12)